Dataset Information

Ambulatory chest physiotherapy in mild-to-moderate acute bronchiolitis in children under two years of age - A randomized control trial.

ABSTRACT:

Objective

The aim of this study was to compare the role of a chest physiotherapy (CP) intervention to no intervention on the respiratory status of children under two years of age, with mild-to-moderate bronchiolitis.

Methods

Out of 80 eligible children observed in the Emergency Room, 45 children completed the study with 28 randomized to the intervention group and 17 to the control group. The intervention protocol, applied in an ambulatory setting, consisted of combined techniques of passive prolonged slow expiration, rhinopharyngeal clearance and provoked cough. The control group was assessed with no chest physiotherapy intervention. The efficacy of chest physiotherapy was assessed using the Kristjansson Respiratory Score at the admission and discharge of the visit to the Emergency Room and during clinical visits at day 7 and day 15.

Results

There was a significant improvement in the Kristjansson Respiratory Score in the intervention group compared to the control group at day 15 [1.2 (1.5) versus 0.3 (0.5); p -value =0.005 , in the control and intervention groups, respectively], with a mean difference (95% CI) of -0.9 ( -1.6 to -0.3 ).

Conclusion

Chest physiotherapy had a positive impact on the respiratory status of children with mild-to-moderate bronchiolitis.

Clinical trial registration

https://clinicaltrials.gov/ct2/show/NCT04260919.

SUBMITTER: Pinto FR

PROVIDER: S-EPMC8221980 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute bronchiolitis.We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n=246) or nasal suction (NS, control group, n=250). Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97-2.73) for the control group and 2.02 days (95% CI 1.96-2.34) for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]=1.09, 95% CI 0.91-1.31, p=0.33). No treatment by age interaction was found (p=0.97). Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]=10.2, 95% CI 1.3-78.8, p=0.005 and RR=5.4, 95% CI 1.6-18.4, p=0.002, respectively). No difference between groups in bradycardia with or without desaturation (RR=1.0, 95% CI 0.2-5.0, p=1.00 and RR=3.6, 95% CI 0.7-16.9, p=0.10, respectively) was found during the procedure. Parents reported that the procedure was more arduous in the group treated with IET (mean difference=0.88, 95% CI 0.33-1.44, p=0.002), whereas there was no difference regarding the assessment of the child's comfort between both groups (mean difference=-0.07, 95% CI -0.53 to 0.38, p=0.40). No evidence of differences between groups in intensive care admission (RR=0.7, 95% CI 0.3-1.8, p=0.62), ventilatory support (RR=2.5, 95% CI 0.5-13.0, p=0.29), and antibiotic treatment (RR=1.0, 95% CI 0.7-1.3, p=1.00) was observed.IET + AC had no significant effect on time to recovery in this group of hospitalized infants with bronchiolitis. Additional studies are required to explore the effect of chest physiotherapy on ambulatory populations and for infants without a history of atopy.ClinicalTrials.gov NCT00125450.

Project description:BackgroundPharmacokinetics (PK), efficacy, and safety of the opioid analgesic tapentadol in the treatment of moderate-to-severe acute pain have so far not been investigated in pediatric patients <2 years of age.Patients and methodsTwo multicenter, open-label trials assessed the pharmacokinetic profile, safety, tolerability, and efficacy of single doses of tapentadol oral solution (OS; NCT02221674; n=19) or intravenous infusion (IV, EudraCT 2014-002259-24; n=38) in children from birth to <2 years of age. Of these, 8 preterm neonates were included in the IV trial. A third randomized, double-blind, placebo-controlled trial (NCT02081391) investigated the efficacy and safety of multiple tapentadol OS doses in patients from birth to <2 years (placebo n=4, tapentadol n=11) using an immediate rescue trial design. Patients in all three trials underwent surgery that, in the investigator's opinion, reliably produced moderate-to-severe pain requiring opioid treatment.ResultsAdministration of single tapentadol doses resulted in tapentadol serum concentrations within the targeted range known to be safe and efficacious in adults and compared well to the range observed for children aged 2 to <18 years. Pain intensity already improved 15 min after administration. In the multiple dose trial, amounts of supplemental opioid analgesic medication within the first 24 h after start of trial medication were low (placebo 0.02 mg/kg, tapentadol 0.05 mg/kg). All patients stopped treatment with the trial medication because opioid analgesics were no longer required. Treatment-emergent adverse events occurred in 42.1% (tapentadol OS single dose), 28.9% (tapentadol IV), and 75% of placebo and 54.5% of tapentadol patients (tapentadol OS multiple doses), none of them serious.ConclusionTapentadol showed a favorable PK and safety profile in children <2 years of age. Multiple tapentadol OS dosing is efficacious and generally well tolerated in children ?2 years and might also be a useful treatment option for children <2 years in need of strong analgesics.

Project description:BackgroundSARS-CoV-2 is an emerging virus that has mainly affected adults; hence, most clinical information has been derived from that population. Most pediatric cases are mild and with nonspecific symptoms requiring outpatient management. Children are a major source of spread for most traditional respiratory viruses. Their role in SARS-CoV-2 transmission was thought to be relevant. Children under the age of two comprise a group that is more susceptible to infection since vaccines have not been approved for them until recently. The knowledge of clinical manifestation of COVID-19 in young children is scarce.ObjectivesTo describe the clinical, epidemiological, and demographic characteristics of children under 2 years old with confirmed COVID-19, who did not require hospitalization.MethodsThis descriptive study was performed from May, 2020 to June, 2021. Children ages 0-2 years with COVID-19, confirmed by transcriptase-polymerase chain reaction assay that were performed in laboratories of the Red de Salud UC CHRISTUS Health Network, were selected to be contacted. If the parents accepted participating and their children were not hospitalized, a survey was sent to the patients' caregivers.ResultsOf the 242 cases, 159 caregivers answered the survey (65.7%). The median age of the subjects was 14 months, and 53.5% were males. Fifty percent had comorbidities, of which one third corresponded to atopy. Ninety eight percent were secondary cases. Most of them were infected within their households (81%). The most frequent sources were their parents, followed by their grandparents. The most common symptom was fever (78%) followed by irritability (67.3%), rhinorrhea (66%), and fatigue (64.8%). Infants less than 6 months old more often presented with conjunctival congestion and less loss of appetite compared to older children (p < 0.05).ConclusionsThis study provides valuable insights regarding COVID-19 in ambulatory young children. Most cases of SARS-CoV-2 infection in children under 2 years old do not require hospitalization. There was a slight male predominance, and the majority had been infected within their households. SARS-CoV-2 infection should be suspected in children under 2 years old presenting with fever, irritability, fatigue, and rhinorrhea. Children with positive household contacts and fever should also be tested for COVID-19.